Eli Lilly treatment solanezumab failed to slow disease
The Eli Lilly logo is seen at one of the company’s offices in San Diego, California, September 17, 2020.
Mike Blake | Reuters
Eli Lilly said Wednesday it will halt development of Alzheimer’s treatment candidate solanezumab after the antibody failed to slow the progression of the disease.
The failure of Solanezumab is a blow to efforts to treat Alzheimer’s in people who are in the very early stages of the disease and have not yet shown clinical symptoms.
The study involved more than 1,000 older adults who had normal memory and thinking function but showed signs of the brain plaques associated with Alzheimer’s.
Solanezumab did not clear or stop the buildup of plaque, called amyloid, and did not slow cognitive decline in participants who received the treatment.
“These data suggest that we may need to be more aggressive with amyloid removal even at this very early stage of the disease,” said Dr. Reisa Sperling, a neurologist at Brigham and Women’s Hospital and director of the study.
Solanezumab was designed to target the plaque that floats in the brain. Lilly is developing two other Alzheimer’s treatments that are in late-stage clinical trials, donanemab and remternetug. These antibodies target plaque that has been deposited in the brain and are designed to treat people who have early symptoms of the disease.
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Lilly expects to release clinical trial data for donanemab in the second quarter of this year. The company plans to ask the Food and Drug Administration to approve the treatment if these data are positive.
Lilly had asked the FDA for accelerated approval of donanemab, but the agency rejected the company’s request in January. The agency told Lilly it must submit data on at least 100 patients who received the treatment for 12 months.
Lilly said it did not have that data because donanemab quickly cleared brain plaque in many patients.
“Because of the speed of plaque reduction we saw, many patients were able to stop dosing as early as six months after starting treatment, resulting in fewer patients receiving 12 months or more of donanemab,” Dr. Dan Skovronsky, Lilly’s chief scientific officer. , analysts were told during the company’s earnings call in February.
“We remain confident in the potential of donanemab as a new treatment for people with early symptomatic Alzheimer’s disease,” Skovronsky said.
The FDA approved Eisai and Biogen’s early Alzheimer’s treatment Leqembi on an accelerated basis in January. The companies expect the agency to make a decision on full approval in July.
Medicare will only cover Alzheimer’s antibody drugs that receive accelerated approval for people who participate in clinical trials. The public health insurance program for seniors said it will offer broader coverage once the FDA gives full approval.